Major Depressive DisorderNCT03429361
Testing the Value of Smartphone Assessments of People With Mood Disorders
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Mindstrong at 1 site in United States.
Trial summary
The purpose of this study is two-fold: 1. To identify the best smartphone data features (based on keyboard, sensor, voice/speech data) that correlate with mood, anxiety, and cognitive assessments in patients with Major Depressive Disorder (MDD) and Bipolar Depression (BD). 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Major Depressive Disorder, Bipolar Disorder
- What is being tested?
- Health by Mindstrong
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Aug 2017to 30 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Adult, Older adult
Study population: The study population includes men and women between the ages of 18 and 65 years, with a diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), currently undergoing ketamine treatment for that disorder.
Who may be able to join
- Adult male or female aged 18 to 65 years (inclusive) at time of informed consent
- Diagnosis of Major Depression Disorder (MDD) or Bipolar Disorder (BD) as assessed using the Structured Clinical Interview for DSM Disorders-Clinical Trials (SCID-CT)
- Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26; Patient Health Questionnaire (PHQ-9) ≥ 15; Clinical Global Impression (CGI) ≥ 4 at screening
- Ownership of a personal smartphone and willingness to install and maintain the Mindstrong app for digital assessments throughout participation in the study
- Able to understand and comply with instructions in English
- Has a significant other who accompanies participant to treatment appointments and agrees to complete assessments
- Undergoing ketamine treatment at the Kadima Clinic, or determined by the Kadima Clinic to be eligible for ketamine treatment and agrees to receive such treatment prior to being asked to participate in this research
Who cannot join
- Female who is currently pregnant or planning a pregnancy within 6 months
- Has any other current Axis I DSM-5 disorder other than MDD or BD, which is the primary focus of treatment
- Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
- Has a visual or physical motor impairment that could interfere with study tasks
- Is site personnel directly affiliated with this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Kadima Neuropsychiatry Institute
La Jolla, California, 92037
About this study
Official title: Testing the Value of Smartphone Assessments of People With Mood Disorders: A Pilot, Exploratory, Longitudinal Study
The purpose of this study is two-fold:
- To identify the best smartphone data features (based on keyboard, sensor, voice/speech data) that correlate with mood, anxiety, and cognitive assessments in patients with Major Depressive Disorder (MDD) and Bipolar Depression (BD).
- To identify the best smartphone data features (based on keyboard, sensor, voice/speech at a) that predict relapse and remission in MDD or BD.
Read the detailed description
Progress in psychiatry will require better measurement. Currently, few clinicians use standard rating instruments for either diagnosis or outcomes. As a result, clinicians often fail to detect when a patient is not improving and fail to adjust treatments accordingly. Yet even with the use of standard rating instruments, there are serious shortcomings because they are used episodically, usually in an office environment, and they rely solely on subjective reports. Given the importance of objective measures of mood, anxiety, and cognition, it is critical for clinicians and patients to have better assessments if we are to achieve better mental healthcare.
The advent of smartphones provides a potential solution for the lack of objective measurement. The wide use of phones gives us the opportunity to collect passive, objective, continuous data relevant to mood, anxiety, and cognition. While several studies have demonstrated the feasibility of digital phenotyping psychiatric patients, the clinical value of this approach has yet to be demonstrated.
Stated simply the question is: can the data from a smartphone be used in clinical practice to improve care? Specifically, will sensor data, keyboard behavior, or voice and speech metrics yield features that can be validated with clinical assessments? Can these features identify relapse and remission even before clinical change is apparent with traditional ratings? Will this information alter care and improve outcomes? This pilot investigation is designed to answer the questions about validation and prediction by studying mood changes in patients treated with ketamine, a rapid-acting antidepressant. The final question about care and outcomes will be addressed separately.
Thus, the current study is a 6 month open, exploratory study that follows longitudinally patients with MDD or BD who are receiving outpatient treatment at the Kadima Clinic. The Kadima Clinic is a private outpatient mental health service providing a range of treatments for people with mood disorders. All patients will be receiving ketamine treatment in the Kadima Clinic; however, this is a study of smartphone features as digital biomarkers, not a study of ketamine efficacy or safety. While the ketamine treatment will not be the focus of this study, its rapid efficacy yields an ideal opportunity for testing and tuning the Mindstrong digital phenotyping app. There will not be randomization, use of placebo, or administration of blinded medication. Patients will be selected based on their willingness to participate in clinical assessments and their use of a smartphone.
The design includes screening and assessment during the week prior to treatment and follow-up at regular intervals for at least 3 weeks and no more than 6 months following treatment. Assessments will be completed by the patient, by a trained clinical rater, and by a significant other.
After completing the enrollment consent, the Mindstrong application (app) is installed in each participant's smartphone. The app is resident on the participant's mobile phone for 6 months. The participant can at any time choose to uninstall the app. The Mindstrong app unobtrusively monitors the participant's use of the mobile phone. The data captured by the app is transmitted over secure channel to a secure data storage site on Amazon Web Services (AWS) cloud infrastructure. All data captured by the app is encrypted.
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Being tested
- Health by Mindstrong
- Medical subject headings
- Depressive Disorder, Major, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health by MindstrongOther
Health by Mindstrong is a smartphone application that collects data on a participant's smartphone usage patterns.
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-D)
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-D at post-treatment and follow-up.
Measured: 6 months
Cognitive Battery
Cognitive Battery includes: Self-report emotional referent task, face-morph task, dot-probe task, choice reaction time, forward digit span, Trails A\&B, digit-symbol substitution test, delayed memory recall, Stroop, Conners Continuous Performance Test, 2-Back test.
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the Cognitive Battery at post-treatment and follow-up.
Measured: 6 months
Hamilton Anxiety Rating Scale (HAM-A)
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-A at post-treatment and follow-up.
Measured: 6 months
Patient Health Questionnaire (PHQ-9)
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict relapse, defined as PHQ-9 > 20 and/or 67% reduction in PHQ-9 improvement between baseline and post-treatment or follow-up, at post-treatment and follow-up.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start8 Aug 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mindstrong
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Kadima Neuropsychiatry Institute
- Responsible party
- Sponsor
- Investigators
- Paul Dagum, MD PhD, Principal investigator, MindstrongDavid Feifel, MD PhD, Principal investigator, Kadima Neuropsychiatry Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03429361
- Sponsor's protocol ID
- 17-01
- Status last verified
- Aug 2019
- First submitted
- 23 Jan 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Value of Smartphone Assessments of People With Mood Disorders: A Pilot, Exploratory, Longitudinal Study
- ClinicalTrials.gov ID
- NCT03429361
- Acronym / sponsor ID
- 17-01
- Conditions
- Major Depressive Disorder, Bipolar Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- MindstrongIndustry (pharma, biotech, devices)
- Collaborators
- Kadima Neuropsychiatry Institute
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 12 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is two-fold:
- To identify the best smartphone data features (based on keyboard, sensor, voice/speech data) that correlate with mood, anxiety, and cognitive assessments in patients with Major Depressive Disorder (MDD) and Bipolar Depression (BD).
- To identify the best smartphone data features (based on keyboard, sensor, voice/speech at a) that predict relapse and remission in MDD or BD.
Detailed description
Progress in psychiatry will require better measurement. Currently, few clinicians use standard rating instruments for either diagnosis or outcomes. As a result, clinicians often fail to detect when a patient is not improving and fail to adjust treatments accordingly. Yet even with the use of standard rating instruments, there are serious shortcomings because they are used episodically, usually in an office environment, and they rely solely on subjective reports. Given the importance of objective measures of mood, anxiety, and cognition, it is critical for clinicians and patients to have better assessments if we are to achieve better mental healthcare.
The advent of smartphones provides a potential solution for the lack of objective measurement. The wide use of phones gives us the opportunity to collect passive, objective, continuous data relevant to mood, anxiety, and cognition. While several studies have demonstrated the feasibility of digital phenotyping psychiatric patients, the clinical value of this approach has yet to be demonstrated.
Stated simply the question is: can the data from a smartphone be used in clinical practice to improve care? Specifically, will sensor data, keyboard behavior, or voice and speech metrics yield features that can be validated with clinical assessments? Can these features identify relapse and remission even before clinical change is apparent with traditional ratings? Will this information alter care and improve outcomes? This pilot investigation is designed to answer the questions about validation and prediction by studying mood changes in patients treated with ketamine, a rapid-acting antidepressant. The final question about care and outcomes will be addressed separately.
Thus, the current study is a 6 month open, exploratory study that follows longitudinally patients with MDD or BD who are receiving outpatient treatment at the Kadima Clinic. The Kadima Clinic is a private outpatient mental health service providing a range of treatments for people with mood disorders. All patients will be receiving ketamine treatment in the Kadima Clinic; however, this is a study of smartphone features as digital biomarkers, not a study of ketamine efficacy or safety. While the ketamine treatment will not be the focus of this study, its rapid efficacy yields an ideal opportunity for testing and tuning the Mindstrong digital phenotyping app. There will not be randomization, use of placebo, or administration of blinded medication. Patients will be selected based on their willingness to participate in clinical assessments and their use of a smartphone.
The design includes screening and assessment during the week prior to treatment and follow-up at regular intervals for at least 3 weeks and no more than 6 months following treatment. Assessments will be completed by the patient, by a trained clinical rater, and by a significant other.
After completing the enrollment consent, the Mindstrong application (app) is installed in each participant's smartphone. The app is resident on the participant's mobile phone for 6 months. The participant can at any time choose to uninstall the app. The Mindstrong app unobtrusively monitors the participant's use of the mobile phone. The data captured by the app is transmitted over secure channel to a secure data storage site on Amazon Web Services (AWS) cloud infrastructure. All data captured by the app is encrypted.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The study population includes men and women between the ages of 18 and 65 years, with a diagnosis of Major Depressive Disorder (MDD) or Bipolar Disorder (BD), currently undergoing ketamine treatment for that disorder.
Key inclusion criteria (7 listed)
- Adult male or female aged 18 to 65 years (inclusive) at time of informed consent
- Diagnosis of Major Depression Disorder (MDD) or Bipolar Disorder (BD) as assessed using the Structured Clinical Interview for DSM Disorders-Clinical Trials (SCID-CT)
- Montgomery-Asberg Depression Rating Scale (MADRS) ≥ 26; Patient Health Questionnaire (PHQ-9) ≥ 15; Clinical Global Impression (CGI) ≥ 4 at screening
- Ownership of a personal smartphone and willingness to install and maintain the Mindstrong app for digital assessments throughout participation in the study
- Able to understand and comply with instructions in English
Key exclusion criteria (5 listed)
- Female who is currently pregnant or planning a pregnancy within 6 months
- Has any other current Axis I DSM-5 disorder other than MDD or BD, which is the primary focus of treatment
- Has any other clinically significant medical condition or circumstance that, in the opinion of the Investigator, could affect patient safety, preclude evaluation of response, interfere with the ability to comply with study procedures, or prohibit completion of the study
- Has a visual or physical motor impairment that could interfere with study tasks
- Is site personnel directly affiliated with this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health by MindstrongHealth by Mindstrong is a smartphone application that collects data on a participant's smartphone usage patterns. | Other | – |
Primary outcome
Hamilton Depression Rating Scale (HAM-D)
Time frame: 6 months
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-D at post-treatment and follow-up.
Cognitive Battery
Time frame: 6 months
Cognitive Battery includes: Self-report emotional referent task, face-morph task, dot-probe task, choice reaction time, forward digit span, Trails A\&B, digit-symbol substitution test, delayed memory recall, Stroop, Conners Continuous Performance Test, 2-Back test. A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the Cognitive Battery at post-treatment and follow-up.
Hamilton Anxiety Rating Scale (HAM-A)
Time frame: 6 months
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict change on the HAM-A at post-treatment and follow-up.
Patient Health Questionnaire (PHQ-9)
Time frame: 6 months
A repeated measures, within-subject design using exploratory techniques will identify the best smartphone usage features or combination of features that correlate with or predict relapse, defined as PHQ-9 > 20 and/or 67% reduction in PHQ-9 improvement between baseline and post-treatment or follow-up, at post-treatment and follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Dagum, MD PhD principal investigator
Mindstrong
David Feifel, MD PhD principal investigator
Kadima Neuropsychiatry Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Depressive Disorder and Bipolar Disorder, run by Mindstrong at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hamilton Depression Rating Scale (HAM-D) (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2019.